WASHINGTON, April 11 - Older patients with dementia who are given antipsychotic medicines are far more likely to die prematurely than those given dummy pills, federal drug regulators said Monday. The warning adds to growing worries about the safety of the widely prescribed drugs.

The Food and Drug Administration said that it would now require manufacturers of the medicines to place black-box warnings - the agency's most severe - on the labels of all the drugs. In 2003, the agency required manufacturers to add a warning about an increased risk of diabetes from antipsychotic medications.

Zyprexa and Symbyax from Eli Lilly, Risperdal from Johnson & Johnson, Seroquel from AstraZeneca, Abilify from Bristol-Myers Squibb, Clozaril from Novartis and Geodon from Pfizer are all affected by the warning.

The drugs belong to a class of medicines developed since 1989 that are supposed to be safer than the older class of medicines for psychosis, like Haldol. In high doses, Haldol and drugs like it can cause a debilitating condition called tardive dyskinesia, a lifelong affliction that can involve uncontrollable trembling, tics and jerky movements.

Doctors have become so comfortable with the safety of the newer medicines that they are now among the biggest selling in the world, with some physicians using them to treat a wide range of conditions, including schizophrenia, depression and dementia in the elderly. Indeed, some psychiatrists prescribe cocktails of antipsychotics to patients with persistent mental problems.

Zyprexa is the biggest drug expense for many state Medicaid programs, the health insurance for the poor.

But the safety of the pills has come under increasing scrutiny. Studies now suggest that the newer drugs are only slightly less likely to cause tardive dyskinesia, and worries about other side effects are mounting.

The Food and Drug Administration said that it had analyzed the results of 17 placebo-controlled trials involving the drugs, which are known as atypical antipsychotics. The agency found that elderly patients with dementia who were given the pills were 1.6 to 1.7 times as likely to die as those given placebos.

The causes of death varied, although most died of heart-related problems like heart failure or infections like pneumonia, the drug agency said.

Representatives for Eli Lilly, AstraZeneca and Johnson & Johnson said the companies were reviewing the F.D.A.'s requirement and would work with the agency to develop new warnings.

The representatives from Eli Lilly and Johnson & Johnson noted that the companies put warnings on their labels about an increased risk of stroke more than a year ago.

The drug agency said it was considering adding the new warning to the older class of medicines "because limited data also suggest a similar increase in mortality for these drugs."

Of all of these, in my experience Clozaril is the most dangerous and individuals on it need to be monitored continuously as there is potential for fatal blood abnormalities, blood pressure problems, heart muscle problems and bowel obstructions.

7
posted on 04/12/2005 12:39:57 PM PDT
by tertiary01
(How many highly paid "professionals" did it take to kill a powerless disabled dependent woman?)

The Food and Drug Administration said that it had analyzed the results of 17 placebo-controlled trials involving the drugs, which are known as atypical antipsychotics. The agency found that elderly patients with dementia who were given the pills were 1.6 to 1.7 times as likely to die as those given placebos.

My dad passed away this past Friday. He suffered from dymentia for a few years. I recognize some of the drugs listed in the article as those that he took. For such a complex problem as mental illness, who knows whether some of the drugs do harm or good. Fifty years ago, what options did people have. You just play with the cards your dealt.

The agency found that elderly patients with dementia who were given the pills were 1.6 to 1.7 times as likely to die as those given placebos.

If the drugs have the desired affect, that of reversing or arresting dementia, then I'd think most folks would gladly accept the increased risk. Most dementia sufferers know what is happening to them, at least in the early stages. It's pretty darn miserable.

OTOH, they only work for some people, and even then sometimes only for a relatively short period.

My Dad had dementia, and died of pneumonia. The drugs they gave him helped at first. I don't know if any of the one's mentioned were what he was taking. I don't live nearby and my Mom and brother never seemed to be able to recall what the drugs he was taking were. Thankfully he only "lived" in the nursing home for three weeks, a miserable three weeks, but only three, before the pneumonia released him from his suffering.

19
posted on 04/12/2005 3:20:42 PM PDT
by El Gato
(Activist Judges can twist the Constitution into anything they want ... or so they think.)

YOU try caring for an angry psychotic person with Alzheimer's disease.

The reason that these drugs are used is because you need to use something...

If you use the older drugs, like Haldol, you end up with people stiff from the parkinson's like side effects.

If you use the even older drugs, like Mellaril, you end up with low blood pressure and people becomeing zombies.

If you use Valium, you end up with zombies with decreased respiration.

If you use nothing, you end up with a person in a nursing home in physical restraints.

Whenever I read these studies, I don't quite believe them. There are too many issues: for example, how many dropped out because of severe behavior problems?

Like ALL drugs, what you need to do is use them only if needed. If Zyprexa means that you can care for grannie who is forgetful but her ordinary sweet self, versus angry, confused grannie who is so bad you lose your health trying to care for her and she ends up in a nursing home...well, maybe it's worth it.

All true. Also, with regard the high cost of a drug like Zyprexa, what is not mentioned here is the cost of not treating someone with schizophrenia. The cost of having someone coming into an ER with full blown psychosis 5 or 6 times a year may be a lot more expensive than having them stay compliant with the meds. Not to mention the cost (emotionally and financially) to the family.

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